System and method for assessing dimensions and eccentricity of valve annulus for trans-catheter valve implantation

• US 9,867,556 B2
• Filed: 02/06/2015
• Issued: 01/16/2018
• Est. Priority Date: 02/07/2014
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Balachandran, Ram Kumar, Venkatasubramanian, Ramji T., Hill, Anthony David, Hauck, John, Saikrishnan, Neelakantan, Thao, Riki
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/615,996
• Publication Number:
  US 20150223729A1
• Time in Patent Office: 1,075 Days
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

A system for detecting the dimensions and geometry of a native valve annulus for trans-catheter valve implantation includes a compliant balloon and a shaft within the balloon. One or more drive electrodes may be affixed to a surface of the balloon, and one or more sense electrodes may be affixed to the shaft. After insertion of the balloon into the native valve annulus, the drive electrodes may be energized with a predetermined voltage. Using a trained statistical model and the voltages measured at the sense electrodes, initial estimates of the cross-section of the valve annulus may be obtained. The initial estimates may then be provided to an optimization model of the valve annulus to obtain a highly accurate prediction of the cross-section of the valve annulus.

Claims

1. A system for determining the dimensions and geometry of a native valve annulus for trans-catheter valve implantation, the system comprising:

a balloon extending in a longitudinal direction and having an interior surface;

a shaft extending in the longitudinal direction within the balloon;

a first pair of electrodes on the interior surface of the balloon and configured to produce a first electrical field based on a first predetermined current;

a second pair of electrodes on the interior surface of the balloon and configured to produce a second electrical field based on a second predetermined current;

a first sense electrode pair on the shaft and configured to detect the first and second electrical fields; and

a second sense electrode pair on the shaft and configured to detect the first and second electrical fields.

2. The system of claim 1, wherein the balloon is an insulative material such that the first electrical field and the second electrical field are confined to an area inside the balloon.

3. The system of claim 1, wherein the first sense electrode pair is at a midpoint of a length of the shaft within the balloon.

4. The system of claim 1, wherein:

an electrode of the first pair of electrodes is positioned at an angle of about 90°

in a circumferential direction of the balloon from an electrode of the second pair of electrodes; and

the second sense electrode pair is positioned at an angle of about 90°

in the circumferential direction of the balloon from the first sense electrode pair.

5. The system of claim 1, further comprising:

a third pair of electrodes on the shaft, one electrode of the third pair of electrodes being positioned a predetermined distance in a first direction along the shaft from the first sense electrode pair and the other electrode of the third pair of electrodes being positioned the predetermined distance in a second direction along the shaft from the first sense electrode pair, the second direction being opposite the first direction, the third pair of electrodes being configured to produce a third electrical field based on a third predetermined current; and

a third sense electrode pair on the shaft and configured to detect the third electrical field.

6. A method for determining the dimensions and geometry of a native valve annulus for trans-catheter valve implantation, the method comprising:

loading a balloon catheter in a delivery system, the balloon catheter comprising;

a balloon extending in a longitudinal direction and having an interior surface;

a shaft extending in the longitudinal direction within the balloon;

a first pair of drive electrodes on the interior surface of the balloon;

a second pair of drive electrodes on the interior surface of the balloon;

a first sense electrode pair on the shaft; and

a second sense electrode pair on the shaft;

delivering the balloon catheter to the native valve annulus;

deploying the balloon catheter within the native valve annulus so that the balloon conforms to a surface of the native valve annulus;

applying a first current to the first pair of electrodes to produce a first electrical field;

applying a second current to the second pair of electrodes to produce a second electrical field;

detecting the first electrical field with the first and second sense electrode pair;

detecting the second electrical field with the first and second sense electrode pair; and

determining one or more dimensions of the native valve annulus based at least on the detected first electrical field and the detected second electrical field.

7. The method of claim 6, wherein the balloon is an insulative material such that the first electrical field and the second electrical field are confined to an area inside the balloon.

8. The method of claim 6, wherein the first sense electrode pair is at a midpoint of a length of the shaft within the balloon.

9. The method of claim 6, wherein the electrodes that comprise the first and second pairs of drive electrodes are affixed about 180°

apart on the interior surface such that the electrodes of the first and the second drive electrode pairs are about 90°

degrees apart on the interior surface; and

the electrodes that comprise the first and sense electrode pairs are affixed about 180°

apart on the shaft such that the electrodes of the first and the second sense electrode pairs are about 90°

apart on the shaft.

10. The method of claim 6, wherein the balloon catheter further comprises:

a third pair of electrodes on the shaft, one electrode of the third pair of electrodes being positioned a predetermined distance in a first direction along the shaft from the first sense electrode pair and the other electrode of the third pair of electrodes being positioned the predetermined distance in a second direction along the shaft from the first sense electrode pair, the second direction being opposite the first direction; and

a third sense electrode pair on the shaft; and

the method further comprises;

applying a third current to the third pair of electrodes to produce a third electrical field;

detecting the third electrical field with the third sense electrode pair; and

further determining the one or more dimensions of the native valve annulus based at least on the detected third electrical field.

11. A method for determining the dimensions and geometry of a native valve annulus for trans-catheter valve implantation, the method comprising:

receiving, with one or more processors, first voltage values from a first sense electrode pair on a shaft of a balloon catheter, the first sense electrode pair being configured to detect a first electrical field produced by a first pair of drive electrodes and a second electrical field produced by a second pair of drive electrodes;

receiving, with the one or more processors, second voltage values from a second sense electrode pair on the shaft of the balloon catheter, the second sense electrode pair being configured to detect the first electrical field and the second electrical field;

determining, with the one or more processors, a major axis length of the native valve annulus based on the first and second voltage values;

determining, with the one or more processors, a minor axis length of the native valve annulus based on the first and second voltage values; and

determining, with the one or more processors, an eccentricity of the native valve annulus based on the determined major axis length and the determined minor axis length.

12. The method of claim 11, further comprising:

determining, with the one or more processors, an estimated major axis length of the native valve annulus by providing the first and second voltage values to a statistical model of the native valve annulus;

wherein the step of determining the major axis length of the native valve annulus includes applying an optimization model of the native valve annulus to the estimated major axis length.

13. The method of claim 11, further comprising:

determining, with the one or more processors, at least one offset value associated with the balloon catheter based on the received first and second voltage values, wherein the at least one offset value identifies an amount of offset of an axis of the balloon catheter relative to an axis of the native valve annulus.

14. A method for determining the dimensions and geometry of a native valve annulus for trans-catheter valve implantation, the method comprising:

loading a balloon catheter in a delivery system, the balloon catheter comprising;

a balloon extending in a longitudinal direction;

a shaft extending in the longitudinal direction within the balloon;

a plurality of splines connected to the shaft;

a first pair of electrodes on a first pair of the splines; and

a second pair of electrodes on a second pair of the splines;

delivering the balloon catheter to the native valve annulus;

deploying the balloon catheter at a first longitudinal position within the native valve annulus so that the balloon conforms to a surface of the native valve annulus at the first longitudinal position;

deploying the plurality of splines so that the splines move radially outward from the shaft;

applying a first current to the first pair of electrodes to produce a first electrical field;

measuring, using the second pair of electrodes, values associated with the first electrical field;

applying a second current to the second pair of electrodes to produce a second electrical field;

measuring, using the first pair of electrodes, values associated with the second electrical field; and

determining one or more dimensions of the native valve annulus based at least on the values associated with the first electrical field and the second electrical field.

15. The method of claim 14, wherein the balloon catheter further comprises:

a central ring electrode located on the shaft, and

the method further comprises;

measuring at the central ring electrode values associated with the first electrical field.

16. The method of claim 15, further comprising:

measuring at the central ring electrode values associated with the second electrical field.

17. The method of claim 14, wherein the balloon catheter further comprises:

a third pair of electrodes on a third pair of the plurality of splines; and

the method further comprises;

applying a third current to the third pair of electrodes to produce a third electrical field;

measuring, using the first pair of electrodes and the second pair of electrodes, values associated with the third electrical field.

18. The method of claim 17, wherein the balloon catheter further comprises:

a fourth pair of electrodes on a fourth pair of the plurality of splines; and

the method further comprises;

applying a fourth current to the fourth pair of electrodes to produce a fourth electrical field;

measuring, using the first pair of electrodes, the second pair of electrodes, and the third pair of electrodes, values associated with the fourth electrical field.

19. The method of claim 14, further comprising:

re-deploying the balloon catheter at a second longitudinal position within the native valve annulus so that the balloon conforms to the surface of the native valve annulus at the second longitudinal position;

applying a third current to the first pair of electrodes to produce a third electrical field;

measuring, using the second pair of electrodes, values associated with the third electrical field;

applying a fourth current to the second pair of electrodes to produce a fourth electrical field;

measuring, using the first pair of electrodes, values associated with the fourth electrical field; and

determining one or more secondary dimensions of the native valve annulus based at least on the values associated with the third electrical field and the fourth electrical field.

20. The method of claim 19, further comprising:

obtaining three-dimensional information about the native valve annulus by combining the one or more dimensions of the native valve annulus and the one or more secondary dimensions of the native valve annulus.